1. Field of the Invention
The present invention is directed to methods for closing and covering suturable wounds under sterile conditions by initially suturing or stapling the wound and afterwards, bonding the area adjacent to the sutures or staples with butyl-2-cyanoacrylate adhesives. The butyl-2-cyanoacrylate formulation to be used is typically stored in sterile dispensers for single use.
2. State of the Art
Cyanoacrylate adhesives have been suggested for a variety of adhesive purposes including glues and surgical adhesives. In particular, cyanoacrylate adhesives of formula I: ##STR1## wherein R is an alkyl or other suitable substituents are disclosed in U.S. Pat. Nos. 3,527,224; 3,591,676; 3,667,472; 3,995,641; 4,035,334; and 4,605,826. Typically, when used as adhesives for living tissues, the R substituent is alkyl of from 2 to 6 carbon atoms and most often is butyl (e.g., n-butyl).
The suggested medical uses for cyanoacrylate adhesives have been limited to surgical environments wherein the cyanoacrylate adhesives are utilized as an alternative to sutures and are employed in a sterile environment. See, for example, Halpern, U.S. Pat. No. 3,667,472. In surgical environments, the subcutaneous layers are typically joined together with sutures and the skin itself is joined either with sutures or with the cyanoacrylate adhesive. When the cyanoacrylate adhesive is employed, it is applied to separate sections of soft skin tissue under sterile conditions and the sections are then joined. Under these conditions, the cyanoacrylate adhesive bonds to the skin as well as polymerizes so as to join separate sections of soft tissue together.
The art discloses that when the cyanoacrylate adhesives successfully bind the skin, incidences of infection are reduced. However, the art also discloses that the use of cyanoacrylate adhesives as suture replacements can be accompanied by occasional adhesion failure resulting in wound reopening which requires closure by sutures. See, for example, Mizrahi, et al., "Use of Tissue Adhesives in the Repair of Lacerations in Children", Journal of Pediatric Surgery, Vol. 23, No. 4 (April), pp. 312-313 (1988). Fear of wound reopening apparently is one of the reasons surgeons have been reluctant to use any adhesives including cyanoacrylate based adhesives in place of sutures.
This invention is directed to methods for treating suturable wounds by first suturing or stapling the wound and then joining the skin between sutures or staples with a cyanoacrylate adhesive. When used in this manner, reductions in the rate of infection are contemplated.
In regard to the above, it is noted that while Morton, et al., Archives of Emergency Medicine, Vol. 5, pp. 110-112, (1988), discloses that butyl-2-cyanoacrylate adhesives can be used as a suture adjunct, the technique for surgical application is not specified. On the other hand, Makady, et al., JAVMA, Vol. 198, No. 11, June 1991, pp. 1932-1934, reports an experimental study using a combination of sutures and n-butyl-cyanoacrylate to close lacerations. This technique describes application of the cyanoacrylate over previously placed sutures in such a manner that the cyanoacrylate becomes entrapped deep in the wound. This technique resulted in inflammation, foreign body reaction, and ineffective healing.